Correlation Between Intestinal Microecology Imbalance and Stroke in Young Adults

Sponsor

Shanghai 6th People's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05113043

Collaborator

(none)

Enrollment

Locations

19.9

Anticipated Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The relationship between the intestinal microecology and stroke has become a research hotspot in neurology field today. Maintaining the balance of the intestinal microbiota are expected to bring new breakthroughs for prevention and treatment of stroke. In recent years, stroke in young adults has an increasing incidence and a considerable socioeconomic impact because of high disability rate and health-care costs. So there is an urgent need to explore the role and mechanism of intestinal microecology imbalance in stroke, especially in the development and prognosis of stroke in young people. This study aims to use multi-omics technologies, including microbial diversity, metagenomics and metabonomics, to reveal the characteristics of intestinal flora in young stroke patients, identify biomarkers for predicting outcome after stroke and early detection of young people at high risk of stroke, and to further explore the role of gut-brain axis in the pathogenesis of stroke.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke Hemorrhagic Stroke

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Research on Correlation Between Intestinal Microecology Imbalance and the Risk and Prognosis of Stroke in Young Adults

Actual Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Ischemic stroke Young patients who suffered from acute ischemic stroke within 12 hours for the first time before entry into the study.
Hemorrhagic stroke Young patients who suffered from acute hemorrhagic stroke within 12 hours for the first time before entry into the study.
Healthy Controls Healthy young people

Outcome Measures

Primary Outcome Measures

Modified Rankin Scale scores [3 months]
0 = No symptoms; 1 = No significant disability. Able to carry out all usual activities, despite some symptoms; 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities; 3 = Moderate disability. Requires some help, but able to walk unassisted; 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted; 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent; 6 = Dead.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Clinical diagnosis of acute ischemic or hemorrhagic stroke
Admission within 12 hours
Aged 18-45 years

Exclusion Criteria:

History of neurological diseases, myocardial infarction, renal and hepatic abnormalities and metabolic diseases
Combined with tumors, inflammatory bowel disease and other digestive system diseases
Combined with serious life-threatening diseases or condition
Any antibiotics, probiotics or prebiotic treatment within 3 months
Deteriorate and die before collecting faecal samples